Amnio-Maxx for Foot Ulcer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, the Amnio-Maxx® Dual Layer Amnion Patch, to determine if it heals diabetic foot ulcers more effectively than usual care alone. Researchers aim to find out if adding this patch to standard treatments can accelerate recovery for wounds that have been difficult to heal. The trial seeks participants who have had diabetes and a foot ulcer for more than four weeks but less than a year, with little improvement from regular care. As a Phase 4 trial, this research explores how the already FDA-approved and effective treatment benefits a broader range of patients.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants, cytotoxic chemotherapy, or topical steroids, you may need to stop them at least 30 days before the trial.
What is the safety track record for the Amnio-Maxx® Dual Layer Amnion Patch?
Research shows that the Amnio-Maxx® Dual Layer Amnion Patch is generally well-tolerated. Studies have found that this patch, used to heal long-lasting diabetic foot sores, has a good safety record. No major reports of serious side effects have been linked to its use. This trial is in Phase 4, indicating that the treatment has already been approved for use and is considered safe. However, like any treatment, minor side effects might occur, but these are usually rare and not serious. Always consult a doctor for more personalized advice.12345
Why are researchers enthusiastic about this study treatment?
Unlike the standard foot ulcer treatments, which typically involve wound cleaning, debridement, and off-loading, the Amnio-Maxx® Dual Layer Amnion Patch offers a unique approach by using amniotic membrane technology. This patch is designed to deliver natural growth factors and anti-inflammatory properties directly to the wound, potentially accelerating healing and reducing inflammation more effectively than traditional methods. Researchers are excited about the Amnio-Maxx patch because it not only promotes faster tissue regeneration but also provides a protective barrier, which might improve outcomes for patients with stubborn foot ulcers.
What evidence suggests that the Amnio-Maxx® Dual Layer Amnion Patch is effective for diabetic foot ulcers?
Studies have shown that the Amnio-Maxx® Dual Layer Amnion Patch aids in healing diabetic foot ulcers. Research indicates that using this patch alongside regular treatment accelerates wound healing. In earlier trials, patients with the patch experienced faster ulcer reduction compared to those receiving only standard care. The current trial will assign participants to either the Amnio-Maxx® Dual Layer Amnion Patch or standard care alone to further confirm the patch's effectiveness. This treatment has already proven effective for diabetic foot ulcers.12346
Are You a Good Fit for This Trial?
This trial is for adults over 18 with Type I or II Diabetes and chronic foot ulcers not healing well. Over half the participants must be older than 65, and they should have adequate blood flow to their feet. Pregnant women can't join, nor can those with severe health issues, allergies to Amnio-Maxx components, cancer treatments, or certain medication histories.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the Amnio-Maxx® Dual Layer Amnion Patch with Standard of Care or Standard of Care alone for the treatment of diabetic foot ulcers
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Amnio-Maxx® Dual Layer Amnion Patch
Find a Clinic Near You
Who Is Running the Clinical Trial?
Royal Biologics
Lead Sponsor